Percutaneous Vertebroplasty Opposite - Infiltration of the Periost and Vertebral Body With Lidocaine - as Pain Palliative Treatment of Osteoporotic Vertebral Fractures of the Thoracic and Lumbar Spine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Pain relief
研究概览
简要总结
The main purpose of this study:
- to determine whether vertebroplasty has a pain palliating effect superior to a sham-procedure for acute painful osteoporotic vertebral fractures of the thoracic and lumbar spine.
Secondary purposes:
- To determine if there are differences in the two methods on preventing forward tilting of the spine and/or shortening of the total height of the spine.
- measure if there are differences in change of lung capacity between the two methods
详细描述
The objective of this study is to evaluate the efficacy of bone cement injection (PVP) for patients with acute painful osteoporotic compression fractures, as compared with a simulated procedure with injection of Lidocaine. Our hypothesis is, that patients who had undergone PVP would report less pain during the first 1-12 weeks and at 12 months (primary outcomes) than those in the sham control group.
The study design of VOPE is a single center double blinded RCT concerning the treatment of patients with a painful osteoporotic VCF. Patients are referred to the principal investigator at Middelfart hospital from the emergency rooms, orthopedics departments, GP's and chiropractors from the Region of Southern Denmark. Prior to enrolling patients randomization-envelopes are constructed in blocks of 20. Upon obtaining informed consent, a study-number is assigned to each patient. The final randomization for each patient, takes place in the operation room upon opening the sealed envelope deciding which of the two operations are to be performed. A total of 80 patients will be enrolled, 40 in each group. This is based on the assumption of a 2.0 point difference in pain relief (VAS Score) and a maximum of 35% withdrawal rate (α=0.05 and β=0.20). The enrolment of patients will take place in a single center, the spine surgery department of Middelfart hospital in Denmark. Randomization will start February 2012 with an expected completion of enrolment by May 2013. There is a one-year follow-up, with the possibility of an extended follow-up at two years.
The overall Institutional Review Board approval is obtained at Middelfart Hospital.
Osteoporosis- and pain medication:
All patients are, in cooperation with the osteoporosis clinic at Odense University Hospital (OUH), DXA-scanned 3 times during the follow-up period, and receives, regarding these results, the correct antiosteoporotic treatment determined by a endocrinology senior consultant. Analgesics are classified following the WHO classification: (1) Paracetamol (acetaminophen), (2) Tramadol, (3) Tramadol and Paracetamol, (4) Morphine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •VCF on X-ray of the spine (minimal 15% loss of height) level of VCF Th6 or lower
- •back pain ≤ 8 weeks at time of surgery
- •≥ 50 years of age
- •bone edema on MRI of the fractured vertebral body
- •focal tenderness on VCF level
排除标准
- •severe cardio-pulmonary condition
- •untreatable coagulopathy
- •systemic or local infection of the spine (osteomyelitis, spondylodiscitis)
- •suspected alternative underlying disease (malignancy)
- •radicular and/or cauda compression syndrome
- •contra-indication for MRI
研究组 & 干预措施
Vertebroplasty
Using fluoroscopic guidance, the practitioner infiltrates the skin and subcutaneous tissues overlying the pedicle of the target vertebra or vertebrae with 1% lidocaine and infiltrates the periosteum of the pedicles with 0.25% bupivacaine (marcaine). 11-gauge or 13-gauge needles are passed into the central aspect of the target vertebra or vertebrae. Bone cement is prepared on the bench and injected under constant fluoroscopy into the vertebral body. Injection is stopped when the cement reaches to the posterior aspect of the vertebral body or leaks into an extraosseous space, such as the intervertebral disk or an epidural or paravertebral vein.
干预措施: Percutaneous vertebroplasty (Procedure)
lidocaine injection
Using fluoroscopic guidance, the practitioner infiltrates the skin and subcutaneous tissues overlying the pedicle of the target vertebra or vertebrae with 1% lidocaine and infiltrates the periosteum of the pedicles with 0.25% bupivacaine (marcaine). 11-gauge or 13-gauge needles are passed into the central aspect of the target vertebra or vertebrae. 2 ml of 1% Lidocaine is injected in each needle. Bone cement is prepared on the bench simulating the vertebroplasty-procedure.
干预措施: Lidocaine injection (Procedure)
结局指标
主要结局
Pain relief
时间窗: 12 Months
Primary outcome will be pain relief at 1 day, 1-12 weeks, and 12 months. The questionnaire consist of the Visuel Analog Score ( VAS score), on a 0-100 scale, where 0 is no pain and 100 is so much pain you can immagine and questions about use, ammount and type of pain medication. Patients are asked to fill out the VAS and Numeric Rating Scale (NRS score), a scale from 0 to 10, where 0 is no pain and 10 is is so much pain you can immagine , and use of analgesics is recorded once every week during the first 3 months after randomization.
次要结局
- Quality of life EQ5D(12 months)
- Subsidence of the affected vertebral bodies and local kyphosis(12)
- Physical function, disability etc.(12 months)
- Lung capacity(12 months)
研究者
Emil Jesper Hansen
MD, PhD
Spine Centre of Southern Denmark